Clinical trials are often performed to determine whether and how a drug, a medical procedure, or a treatment affects a particular type of patient or patients in general. Medical data regarding participating patients can be obtained over time during the course of a clinical trial, and analyzed. Various types of medical data of patients can be obtained and analyzed during clinical trials. One type is an electrocardiogram (ECG or EKG). An ECG is a representation of electrical activity over time of a patient's heart.
An ECG can be valuable information that indicates, for example, whether a drug or other medical procedure is affecting a patient's heart function. An ECG can be obtained at a clinical trial test site—which may be a medical provider office that is implementing the clinical trial—but analyzed at a remote location by a cardiologist.
An ECG is often a graphical representation of the electrical activity. Technicians or other personnel can obtain measurements from the graphical representation. Examples of measurements include QT, PR, ST, and RR intervals. A cardiologist can review and analyze the measurements to determine whether a patient's heart may be affected by a drug or other medical procedure. The cardiologist can issue a report that is associated with the patient.
Computer systems can be used to manage clinical trial data acquisition, analysis, and storage. Computer systems can be used to provide an ECG for measurement by a technician using a computer interface and for review by a cardiologist using another computer interface. Computer systems can provide data associated with a protocol such that the ECGs are measured in accordance with the data associated with the protocol. The computer systems can allow the technician, cardiologist, data storage, and clinical trial site to each be in a separate location with respect to each other, and continue to process ECGs. The computer systems can also support electronic submission of ECGs and reports to the clinical trial organizers and to the Federal Drug Administration (FDA) in a format acceptable to the FDA.
Such computer systems may be unable to manage the ECGs among technicians that measure the ECGs and among cardiologists that review the measured ECGS efficiently to meet one or more deadlines associated with the clinical trial, or other clinical trial-related factors. For example, such computer systems may be unable to select intelligently a technician to measure an ECG of a patient or a cardiologist to review the measured ECG. Furthermore, such computer systems may be unable to process ECGs efficiently in view of a modification to data associated with a protocol to, for example, meet one or more deadlines (or other requirements) in accordance with the modification.
Accordingly, systems and methods are desirable that can allow ECGs to be processed efficiently while accounting for a modification to a protocol.